510(k) · Cleared
Recalled · Class II · 2023MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invatec S.P.A. · NTE Temporary Carotid Catheter For Embolic Capture
Cleared on Oct 15, 2009 as substantially equivalent to K083300 (W. L. Gore & Associates, Inc., 2009) after an 86-day review. Its family tree reaches back 6 generations to 2001. It has been recalled 3 times.
- Decided
- Oct 15, 2009
- Review
- 86 days
- Class
- Class II
- Product code
- NTE
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 6 generations to K003992 (2001). 28 ancestors in all, the oldest K990487 (1999). No later device cites it as a predicate yet.
- Root · 6 generations backK003992 Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
- 5 generations backK023691 Boston Scientific Filterwire EX EmbolicBoston Scientific Epi · 2003
- 4 generations backK042218 Accunet Embolic Protection System, RX Accunet Embolic Protection…Guidant Corp. · 2004
- 3 generations backK052166 Modification to: RX Accunet Embolic Protection SystemGuidant Corporation · 2005
- 2 generations backK072990 Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc. · 2007
- 1 generation backK083300 Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009
- This deviceK092177 MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | 2001 | — |
| −5 | K023691 | Boston Scientific Filterwire EX Embolic | Boston Scientific Epi | 2003 | — |
| −4 | K042218 | Accunet Embolic Protection System, RX Accunet Embolic Protection System | Guidant Corp. | 2004 | — |
| −3 | K052166 | Modification to: RX Accunet Embolic Protection System | Guidant Corporation | 2005 | — |
| −2 | K072990 | Guardwire Temporary Occlusion and Aspiration System- Carotid | Medtronic, Inc. | 2007 | — |
| −1 | K083300 | Gore Flow Reversal System | W. L. Gore & Associates, Inc. | 2009 | — |
| 0 (this device) | K092177 | MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6 | Invatec S.P.A. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NTE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NTE device
- #1 K222694 EmPro EPS (EP4514C-190…score 6.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083300 | Gore Flow Reversal SystemSummary page 1…me: Cerebral Protection Device Regulation Name: Catheter, carotid, temporary, for embolization capture Predicate Device · GORE Flow Reversal System (K083300) Device Description The MO.MA® ULTRA Proximal Cerebral Protection Device consists of a multi-lumen shaft integrating two compli… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 12, 2023 | Class II | Z-0320-2024 | Process control | The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA)… |
| Oct 12, 2023 | Class II | Z-0321-2024 | Process control | The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA)… |
| Oct 12, 2023 | Class II | Z-0322-2024 | Process control | The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 28 ancestors have a recall of any class.
- 2 other devices also cite its predicate K083300.
How does its category compare?
All NTE devicesNTE Temporary Carotid Catheter For Embolic Capture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NTE
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NTE
105in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NTE
3in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · NTE
405in 2025
MAUDE reports naming product code NTE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 119 |
| 2008 | 3 | 95 | 6 | 368 |
| 2009 | 3 | 86 | 0 | 343 |
| 2010 | 1 | — | 0 | 294 |
| 2011 | 4 | 105 | 1 | 304 |
| 2012 | 3 | 30 | 0 | 261 |
| 2013 | 0 | — | 0 | 258 |
| 2014 | 1 | — | 0 | 199 |
| 2015 | 3 | 105 | 0 | 148 |
| 2016 | 1 | — | 0 | 148 |
| 2017 | 0 | — | 0 | 141 |
| 2018 | 1 | — | 0 | 158 |
| 2019 | 1 | — | 0 | 233 |
| 2020 | 1 | — | 0 | 238 |
| 2021 | 1 | — | 1 (1) | 327 |
| 2022 | 1 | — | 0 | 326 |
| 2023 | 2 | — | 3 | 354 |
| 2024 | 0 | — | 0 | 398 |
| 2025 | 0 | — | 0 | 405 |
| 2026 | 0 | — | 2 (2) | — |
What is it indicated for?
The MO.MA® ULTRA Proximal Cerebral Protection Device is indicated as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures involving lesions of the internal carotid artery and or the carotid bifurcation. The reference diameter of the external carotid artery should be between 3-6 mm and the reference diameter of the common carotid artery should be between 5-13 mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092177: MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092177
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026